Quality Engineer
Core
Developing and maintaining quality evaluation and control systems, conducting inspections and tests, and performing root cause analysis to ensure reliability standards for medical device products and equipment.
Role type
Associate II Quality Assurance Engineering (Science/Tech/Engineering Path)
Builds
Quality evaluation and control systems, inspection and testing processes, and validation activities for medical devices.
Domain
Medical devices / Manufacturing automation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
PLC, HMI, and SCADA systems; quality systems and compliance requirements; root cause analysis; statistical analysis; computerized system validation (CSV); data integrity (DI); risk-based validation; SOP development; change management.
Preferred skills
Electrical Engineering background; experience with packaging machines; fresh graduates with strong technical knowledge in automation systems.
Technologies
PLC, HMI, SCADA
Responsibilities
Develop, implement, and maintain quality evaluation and control systems and protocols; Design and improve inspection, testing, and evaluation processes for products and equipment; Conduct quality assurance testing and statistical analysis to ensure process control and mitigate risks; Perform root cause analysis and lead corrective and preventive actions (CAPA); Review and approve investigations, CAPAs, validations, and verifications; Ensure compliance with FDA 21 CFR Part 11 and EU Annex 11 requirements; Execute and approve computerized system validation (CSV) and qualification activities; Apply risk-based validation approaches and perform system GAP assessments; Collaborate with cross-functional teams on CSV and data integrity (DI) initiatives; Develop and improve SOPs, guidelines, and validation processes; Support digitalization and global e-compliance initiatives; Lead or support change management activities for system/process improvements; Provide quality oversight for computerized systems and ensure lifecycle compliance; Deliver CSV/DI training and support compliance improvement programs; Partner with manufacturing teams to drive process improvements; Ensure adherence to HSE (Health, Safety, and Environment) procedures.
Seniority
Associate II, hands-on IC